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OCATA THERAPEUTICS, INC. Message Board

beareclawe 535 posts  |  Last Activity: 15 hours ago Member since: Jan 10, 2011
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  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe Mar 14, 2015 7:48 PM Flag

    Re: It's not what I know but what I can prove...

    Citations:

    "What happened to your asscandypost? BUSTED !"

    freddyaophelps • 16 hours ago
    cake_monkey_mayhem • 4 minutes 40 seconds ago
    What happened to your asscandypost? BUSTED ! : )

    "What are you talking about? How, and for what, am I being "BUSTED"? "

    cake_monkey_mayhem • 14 hours ago
    What are you talking about? How, and for what, am I being "BUSTED"? A serious effort to try and fathom just WhatTheFishcakes you're babbling about. The facts are few, but it's best to start with a list of them:
    - I made a post
    - 4 min 40 sec later you copied the header of that post
    - Somebody else didn't make a post(?) Not really sure about this one, but it seems to be implied
    - Because they didn't make a post (at the same time, I guess?) you see it as proof of something.
    Well, I see it not as proof, rather supporting evidence for the theory that when you were a baby you had been dropped on your head...several times.

    "The whole 'being dropped on your head' thing continues to this day, doesn't it...."

    cake_monkey_mayhem • 14 hours ago
    The whole 'being dropped on your head' thing continues to this day, doesn't it. You are a sad, strange little man, and you have my pity. Farewell.

    : ) Please seek professional help for impaired brain and cognitive function.

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe Mar 14, 2015 7:14 PM Flag

    Re: freddyaophelps
    ......................................, eh gastrodumas?

    freddyaophelps • Mar 13, 2015 1:32 PM
    How you feeling today gastradumas, you look constipated in your picture.

    beareclawe • Mar 13, 2015 1:53 PM
    Re: How you feeling today gastradumas, you look constipated in your picture.
    Please post the pic, and any incriminating facts.
    : ) Pixels are mightier than the sword.

    beareclawe • Mar 13, 2015 4:11 PM
    Re: Please post the pic, and any incriminating facts.
    Nada ?
    : ) When freddy lies he speaks his native language.

    : ) Yup, when freddy lies he speaks is native language.

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe Mar 14, 2015 6:53 PM Flag

    Re: We were pleased with the reception we received from several high-quality investors, ...

    The altruistic, genetically superior, german intelligence-trained being oughta convince the wife to let go of her pur$e $tring$.

    Citations:

    "I personally know Siegfried (fighter) .... gives of himself and his money to folks that need,, he is always out to help those in need ....."

    bum5353 • Feb 15, 2014 3:52 PM
    I personally know Siegfried (fighter) for several years,, he is a man of integrity, kindness, and a gentleman,, so what, he is wealthy, but he does not flaunt his wealth in real life and gives of himself and his money to folks that need,, he is always out to help those in need,, he does not need to be taxed out the a*()s as some would want him to be,, he gives more than taxed anyway out of his goodness,, so for those of you who bash the hell out of him, you are dead wrong of your assessment of his character,, and for those who do, take a look in the mirror and tell yourself what have you done for your fellow man this past week,, how honest can you be with yourself,, C

    "There is this FIGHTERPILOT from Germany, smart and good looking."

    fighterpilot, 17-Apr-12 01:03 pm
    keep let me ask you a question What do you not understand on such a simple story. There is this FIGHTERPILOT from Germany, smart and good looking. He marries into a vast fortune of oil, farming and banking and he becomes an investor after he retires from the military. Are you really THAT stupid to understand such a simple story which as I have stated before was featured in an old Playboy Magazine, which is right here in my desk.

    "Deme you know my German background in intelligence. It was my area of expertise, ..."

    fighterpilot, 7-May-12 09:37 am
    Deme you know my German background in intelligence. It was my area of expertise, I have explained the situation to so many friends, but the last thing a lot of those folks like to do, is to listen to those who are experts in a certain field. They rather hear what they like to hear and there are plenty who want to get elected or sell their paper.

    : ) POPCORN POOOOPCOOOORN

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe Mar 14, 2015 6:44 PM Flag

    Re: Maxim? Hold!!!
    dsroyal91 Sentiment: Strong Buy

    "In a research report published Friday, Maxim Group analyst Jason Kolbert downgraded shares of Ocata Therapeutics (NASDAQ:OCAT) from Buy to Hold...."

    Citation:

    Maxim Downgrades Ocata Therapeutics As There May Be Downside From Current Levels
    December 19, 2014 5:37 PM EDT by Ben Mahaney

    In a research report published Friday, Maxim Group analyst Jason Kolbert downgraded shares of Ocata Therapeutics (NASDAQ:OCAT) from Buy to Hold, as the company plans to raise capital by issuing 10M new shares. No price target was provided. Kolbert noted, “The capital raise news was announced on December 2, 2014 and we have not heard of any progress since then. We view management being radio silent as a bad sign. We conclude that the target raise of ~$50 million may be beyond the reach of this company without highly discounted terms. As such there may be downside from current levels. Our concern is the time that has passed with no news and the quality of terms.” The analyst concluded, “We like the fundamental science and technology but we are concerned that the near-term risk as a result of the announced financing could result in a substantially lower stock price. As such, we feel compelled to lower our rating to hold and suspend our price target until we have more clarity on the outcome, at which time we can revisit the fundamentals.”

    CC
    March 12, 2015
    (excerpt)
    Ted Myles: As of December 31, 2014, we had approximately $4.4 million dollars of cash and cash equivalence on hand and approximately $18.6 million dollars available to us under our arrangement with Lincoln Park Capital. As previously disclosed, we initiated the process of marketing the company to institutional investors in the 4th quarter of last year. We were pleased with the reception we received from several high-quality investors, and now that we have achieved the NASDAQ listing and we're nearing the initiation of our Phase II clinical trials, we look forward to reengaging the market and ultimately attracting institutional capital into Ocata. We look forward to updating you further as we continue to make progress against our plan, and we appreciate your continued support. Now I'll turn the call back to Paul.

    : )

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe Mar 14, 2015 6:25 PM Flag

    Re: Maxim? Hold!!!
    dsroyal91 Sentiment: Strong Buy

    Maxim Sees Major Upside In These Biotech Stocks
    By Wayne Duggan
    3 hours ago
    (excerpt)
    Ocata Therapeutics Inc (OTC: OCAT)
    Analysts like the fundamental science and technology that Ocata brings to the table, but they are concerned about the near-term funding risk the company faces after it failed to close a $50 million funding raise in late 2014. Maxim has a Hold rating on Ocata.

    CC
    March 12, 2015
    (excerpt)
    Paul Wotton: Operator can you now open up the call to any analysts that are on the line?

    Jason Kolbert: Hi guys. This is actually Jason McCarthy for Jason Kolbert. It sounds like everything is moving in the right direction, and it sounds like the trials are starting up, it's going to be exciting. I wanted to go back to the financials a little bit, and I know it's disappointing to have not gotten a deal done at the end of last year, and if you're going to do it this year, what point in the trial, or how much data do you think you're going to need to kind of drive that forward, and just make it successful this time around?

    Paul Wotton: Well, the question really is about the progress we're making on the clinical trial front, and the important thing that we learned over the last quarter. There's a number of things that happened, the first is we have positive data from the Lancet. The second thing is towards the end of December, early part of the year, we started realizing that we'd have to change the way we designed our clinical trials to include control patients, which actually just changed the way that people view our company. We did have a meeting with the European Medicines Agency February 4th of this year, and as a result of that meeting, as well as continued dialogue we've had with other agencies, we have changed the design of both the dry AMD study and the Stargardt's disease study to ensure that we include a control group of patients, which we believe will give us a better outcome. It also harmonizes, we think, the studies between what the FDA will require for approval and what the European Agencies will require for approval, and as we mentioned on the call as well, we are also looking into the possibility of getting a Special Protocol Assessment with the FDA, which will help to de-risk the programs that we are working on and make the approval process more expeditious for us. So what we've tried to do in the past quarter is focus quantitatively on improving the design of our clinical studies.

    Jason McCarthy: Thank you. I caught it before, but the new control is going to be what? No treatment, I missed it.

    Paul Wotton: No, we actually didn't specify what the control is going to be, so you didn't miss anything.

    Jason McCarthy: Okay, so I didn't miss it then.

    Paul Wotton: The way we're going to do this, patients who are getting the therapy will receive the therapy. Control patients will not be receiving the therapy, but they will be put into a procedure, including being taken into the surgical room, where they will appear to have received the therapy. It's fair to say that we won't be doing a subretinal injection of anything like saline in that study, but it's important, this is about as close a control as we can get for these patients without crossing over the boundary of being unethical.

    Jason McCarthy: Right. Okay great, thank you so much.

    : )

  • beareclawe beareclawe Mar 14, 2015 7:08 AM Flag

    Re: When developing a new drug........

    " Lot of folks here don't realize that Dr. Lanza's cells are not drugs,..."

    tony_montello2003 • Mar 7, 2015 12:27 AM
    Lot of folks here don't realize that Dr. Lanza's cells are not drugs, you can't make a generic version.
    Let the fact's be known, Dr. Tony Montello

    Citation:

    "The court ultimately decided that the stem cell products at issue were a drug ......."

    DC Circ. Opens Door For Stem Cell Regulation By FDA
    Law360, New York (March 07, 2014, 5:02 PM ET)
    By Stacie L. Ropka and Chad Landmon, Axinn Veltrop & Harkrider LLP

    (excerpts)

    The court ultimately decided that the stem cell products at issue were a drug under the Federal Drug and Cosmetic Act and/or a biologic drug under the Public Health and Safety Act (“PHSA”).[1] Furthermore, the court ordered a permanent injunction preventing Regenerative from using the autologous stem cells in medical procedures. Recently, the D.C. Circuit affirmed the district court’s decision.[2]

    [1] See U.S.A. v. Regenerative Sciences LLC et al., 878 F. Supp. 2d 248, 257 (D.D.C. 2012).
    [2] U.S.A. v. Regenerative Sciences LLC et al., No.12-5254, slip op. (U.S. App. D.C. filed Feb. 4, 2014).

    The FDA defines human cells, tissues or cellular-/tissue-based products (“HCT/Ps”) as “articles containing or consisting of human cells or tissues that are intended for implantation, infusion or transfer into a human recipient.”[3]

    [3] 21 C.F.R. § 1271.3.

    Stacie Ropka, Ph.D., is counsel in Axinn Veltrop & Harkrider's Hartford, Conn., office, where she advises clients on biologics, stem cells and other tissue-based therapies and diagnostics.

    Chad Landmon is chairman of Axinn Veltrop & Harkrider's intellectual property and U.S. Food and Drug Administration practice groups in the firm's Hartford, Conn., office. Landmon actively litigates and advises clients on patent and FDA matters, including those involving biologics and stem cells.

    : )

  • beareclawe beareclawe Mar 14, 2015 7:00 AM Flag

    Re: When developing a new drug........

    CC
    March 12, 2015

    Wotton: "The second thing is towards the end of December, early part of the year, we started realizing that we'd have to change the way we designed our clinical trials to include control patients, ..."

    : ) D'oh !

  • beareclawe beareclawe Mar 14, 2015 6:28 AM Flag

    Re: For those of you wondering........

    Pharma & Healthcare 12/01/2014
    John LaMattina
    Should The FDA Force Drug Makers To Discuss Their Clinical Trials?
    When developing a new drug, biopharmaceutical companies design clinical trials which, if successful, will garner approval from the FDA and other regulatory agencies around the world. Late stage clinical trials are time consuming and costly, with expenses running into tens, even hundreds, of millions of dollars. Oftentimes, you get only one chance to run such a program and so it’s important to get the design right. Thus, it behooves companies to meet with the FDA to discuss their protocols to get a sense of whether the FDA will approve the drug pending a successful outcome with regard to safety and efficacy. In fact, the FDA has a procedure known as a special protocol assessment (SPA) which can be requested by any company to get the FDA’s views on the trial design for its experimental medicine. When the FDA formally endorses a SPA, it essentially endorses the protocol thereby giving a company confidence that, if the drug performs as hoped, the FDA will readily approve it.

    Surprisingly, not all companies actually seek such FDA guidance before embarking on their clinical trials. As revealed in a recent research letter to the Journal of the American Medical Association (JAMA) ), of the 35 drugs approved from February 1, 2011 to February 29, 2012, companies met with the FDA to discuss pivotal studies for 28. Furthermore, for those drugs that were discussed, the FDA made 53 recommendations to alter or modify the study protocols and only 40 were accepted.

    Companies are not required to meet with the FDA to discuss their trial design. Nor are they required to follow their recommendations. (It should be noted that all clinical trial protocols must be reviewed and approved by Institutional Review Boards, also known as Ethical Review Boards, at the hospital or clinic where the trial is being conducted. Thus, independent oversight for these studies exists.) The JAMA authors believe this is a situation that should be corrected by making FDA reviews of all clinical trial designs mandatory.

    “One approach for enhancing quality of drug approval studies would be to institute mandatory FDA review of pivotal trial protocols with the power to issue binding recommendations, which may be even more important with increasing flexible approval pathways. An independent FDA-commissioned report suggested that stronger early FDA involvement could avoid deficiencies that delay approval of effective drugs and more clearly identify ineffective or harmful ones.”

    What is surprising about the JAMA report is that the FDA actually approved seven drugs whose protocols they hadn’t reviewed ahead of time. This type of behavior is risky on the part of the drug sponsors. Drug development is inherently difficult. Proceeding without seeking any FDA guidance increases the risk dramatically. Adhering to FDA recommendations, however, tends to be a judgment call. To be frank, not every FDA recommendation warrants follow-up. Some are “nice-to-have” but are not critical to understanding the safety and efficacy of a new drug. Furthermore, a company may develop a trial design that is unprecedented and makes the decision to go ahead with an innovative design without the FDA’s blessing in order to advance science. Not all FDA recommendations are equal – some are more critical than others.

    However, the FDA can and does reject New Drug Applications that do not meet its standards of safety and efficacy. The JAMA paper only analyzed approved drugs. It is likely that the FDA rejected drugs that had lower compliance with its recommendations or where no guidance was sought. Nor do the authors include those cases where the FDA required further studies to be done post-approval.

    Making it mandatory for the FDA to review and provide guidance for all pivotal clinical trials seems to be overkill. In fact, the JAMA data show that drugs can be approved without such interactions. Companies need to be able to have the freedom to conduct their studies to meet not just the needs of patients and physicians, but also their own capabilities as well. However, not seeking FDA guidance adds a layer of risk for bringing important new drugs to patients in need. Without prior FDA buy-in, this agency is also free to reject the drug. When it comes to avoiding FDA guidance, drug companies beware.

    : )

  • beareclawe beareclawe Mar 13, 2015 8:52 PM Flag

    bump for the :

    rabidly optimistic, unconscionable, and conjecture-based
    anxious and desperate
    spin/pump chimps

    : )

  • Reply to

    OCAT closes green today

    by booskiadam Mar 13, 2015 9:36 AM
    beareclawe beareclawe Mar 13, 2015 6:59 PM Flag

    Re: At least I've had opinions of my own.

    Me too..... but I'm beareclawe, and my beare thoughts are not your thoughts, neither are your ways my beare ways. As the celestial heavens are higher than the earth, so are my beare ways higher than your ways, and my beare thoughts than your thoughts.

    Re: The only thing you do is cut and past.

    Usually, what I 'cut and paste' are facts. That's bearecraft.

    Re: You add no value to any thread you've ever been a part of.

    That's a matter of perspective.... for mb readers.

    Re: You are just a flunkie for the cross-dresser and keep_boring_me.

    Enable or flag the 'Ignore User.' Are you indecisive and/or lack self-control ?

    : )

  • Reply to

    Publication of data in Asian patients this month

    by clautam33 Mar 3, 2015 9:22 AM
    beareclawe beareclawe Mar 13, 2015 6:03 PM Flag

    Re: ..... don't forget his research "partner"- I believe it's Dr Mei Suk Yu, she's amazing they say, just brilliant at what she does......

    LOL

    Re: .......the world-renowned stem cell researcher, ...........

    Actually, the south korean researcher got into trouble back in 2006 for faking his stem cell research, among other things.

    : )

  • Reply to

    Asian Patients?

    by blackmarango Mar 13, 2015 12:47 PM
    beareclawe beareclawe Mar 13, 2015 5:06 PM Flag

    Re: I view thumbs down as a Badge of Honor. The more that I get, the better was my post.

    It's all a matter of perspective.

    What is truth with regard the hand or thumb signal in the 1872 Pollice Verso painting by Jean-Léon Gerome ?

    : )

  • beareclawe beareclawe Mar 13, 2015 4:32 PM Flag

    Re: Do any of you clowns POSTING MESSAGES here think it affects the PPS ?

    Ka-ching, Ka-ching, Ka-ching, KACHINA$

    : )

  • Reply to

    OCAT closes green today

    by booskiadam Mar 13, 2015 9:36 AM
    beareclawe beareclawe Mar 13, 2015 4:29 PM Flag

    Re: I don't care about the daily pps ....... 6 months from now I expect us to be well above this level and by then I also suspect you'll be just a bad memory,........

    " I haven't been right about anything yet."

    Citation:

    rodzwc • Mar 10, 2015 4:29 PM
    Demeter, I don't know where you're coming from most of the time but regardless, I pay no attention to anything past CEOs have said. PW said partner non-core in 2nd quarter. I'm going to assume he means it because PW has given me no reason to think he is a liar. It appears to me this is going to be the source of our funding for the company. We have had many catalysts that should have moved the pps up but didn't. I believe, now that we are on NADASQ, our main hold back is uncertainty on funding. Once that is spelled out, we'll see new investors and the pps will move up, and any further PRs on company news should act as true catalysts. Just my opinion and disclosure: I haven't been right about anything yet.

    : )

  • beareclawe beareclawe Mar 13, 2015 4:22 PM Flag

    Re: .....The attack is psychological ............

    (excerpts)
    Ignore Investment Tips from Stock Message Boards, Say Researchers

    Prabhudev Konana, Alok Kumar, Raj Raghunathan and Bin Gu are Ph.D. researchers in marketing, finance and information systems at The University of Texas at Austin and the University of Miami. They claim message boards cause good investors to make bad decisions. "It's not as simple as saying, 'Well, it is harmless entertainment,'" says researcher Kumar. "There is real risk you will be influenced by the 'noise' and begin to amplify your own investment biases."

    "Individual investors exhibit what is called confirmation bias," says Konana. "They select and read information that conforms to their own preconceived biases, and as a result they actually become more confident in their opinion and trade more frequently, but with lower overall returns." This runs counter to the concept that investors are rational information gatherers. "Behavioral finance studies tell us investors are subject to all manner of psychological biases," he says. "And message boards contribute to these biases, actually amplifying them, particularly for investors with strongly held opinions."

    : )

  • beareclawe beareclawe Mar 13, 2015 4:11 PM Flag

    Re: Please post the pic, and any incriminating facts.

    Nada ?

    : ) When freddy lies he speaks his native language.

  • Reply to

    Asian Patients?

    by blackmarango Mar 13, 2015 12:47 PM
    beareclawe beareclawe Mar 13, 2015 4:06 PM Flag

    Re: ......... the Good Dr Wotton has added more stock dilution, changed the company name, did a RS, and uplisted, yet so far it hasen't helped the shareholder one iota, but he and his staff get paid nice salaries, with yearly raises, along with tons of free stock. Nice racket, huh.

    "Nice racket, huh."

    : ) yup

  • beareclawe beareclawe Mar 13, 2015 3:54 PM Flag

    Re: Spent some time with Merck I see. So he's probably familiar with the aforementioned practice.

    Yea, then there is Anglade..........

    Press Releases
    December 12, 2013
    Advanced Cell Technology Appoints Eddy Anglade M.D. Executive Vice President of Clinical Development
    Company Strengthens Clinical Team as it Nears Phase II Trials in AMD and SMD
    (excerpt)
    MARLBOROUGH, Mass.-- Advanced Cell Technology, Inc. (“ACT”; OTCBB:ACTC), a leader in the field of regenerative medicine, today announced the appointment of Eddy Anglade, M.D., to the newly created position of Executive Vice President of Clinical Development. Dr. Anglade is an ophthalmologist and an experienced pharmaceutical executive with more than 16 years of experience overseeing all elements of clinical trials and regulatory affairs.

    “We created the new position, EVP of Clinical Development, as we prepare for our transition to Phase II of our AMD and SMD clinical trials. We are thrilled to welcome such an experienced and accomplished executive to our team at this critical point in the Company’s evolution,” said Gary Rabin, CEO of ACT. “Dr. Anglade has extensive experience in the development of therapeutics for treating diseases of the eye. He will make an excellent addition to the world-class management team at ACT as the Company continues to work with its clinical development partners at many of the leading academic and scientific institutions in the world.”

    Dr. Anglade joins ACT after co-founding Lux Pharmaceuticals and serving as its Chief Medical Officer, where he guided the development of orphan designated and fast-track products as well as early phase development of a novel therapeutic agent for dry eye disease. His responsibilities included recruitment and development of the clinical operations, program management, and medical writing teams, as well as serving as the safety officer responsible for review of all studies. Previously he was Vice President of Clinical Development at Enzon Pharmaceuticals, where he oversaw all clinical development activities and was a member of the research and development leadership team, and designed the industry’s first multi-center, randomized, placebo-controlled and blinded study of an agent for the prevention of rejection in lung transplantation. He served as a medical director for Hoffman-La Roche Inc. where he developed and implemented clinical strategies for their CellCept® and Cytovene® drugs and served as the medical monitor for Zenapax® in cardiac transplantation. Dr. Anglade holds an M.D. from Yale University. He completed his residency in ophthalmology at Massachusetts Eye and Ear Infirmary/Harvard Medical School, and received additional training in ocular immunology at the National Eye Institute/National Institutes of Health. He is an extensively published author in eye disease and immunology.

    “ACT is a great opportunity. The data from the Phase I AMD and SMD trials are very encouraging. I am excited to join the team and look forward to helping in guiding the clinical and regulatory strategy as the Company progresses through its clinical trials, ultimately toward market approval,” commented Dr. Anglade. “Macular degenerative diseases represent large and important unmet medical needs. I look forward to applying my experience in this field to move ACT’s novel therapies to the tens of millions of patients suffering from these diseases.”

    : )

  • beareclawe beareclawe Mar 13, 2015 1:53 PM Flag

    Re: How you feeling today gastradumas, you look constipated in your picture.

    Please post the pic, and any incriminating facts.

    : ) Pixels are mightier than the sword.

  • Reply to

    Publication of data in Asian patients this month

    by clautam33 Mar 3, 2015 9:22 AM
    beareclawe beareclawe Mar 13, 2015 1:45 PM Flag

    Re: Publication of data in Asian patients this month

    Yea, I believe the world-renowned stem cell researcher, Hwang Woo-suk , is feverishly compiling the data for publication.

    : )

ACTC
6.97+0.17(+2.50%)Nov 13 3:59 PMEST